The GA4GH Regulatory and Ethics Working Group (REWG) has published a new policy online developed by its Ethics Review Equivalency Task Team. We spoke with Edward Dove, Coordinator of the Task Team and a lead author on the policy, to tell us more about how this important new document will make it easier for institutions to share human subjects research data across national boundaries.

BaseBytes: Describe the purpose of the new ERE Policy.

Edward Dove:The purpose of the ERE Policy is to improve how research ethics committees review research projects that involve health-related data across several countries in the world. It does this by listing key elements for the process of ethics review. The goal is that ethics committees and others would recognise and endorse these elements so that ethics reviews conducted by various committees in different countries would be recognised as equivalent. We believe recognition of equivalent ethics review processes can improve the efficient and responsible sharing of health-related data.

BB: How will the ERE Policy advance genomic and clinical data sharing, and ultimately human health?

ED: Research ethics committees review the ethical acceptability of research involving human participants. Ethics committees aim to protect participants from physical harms and to promote participants’ interests and welfare. The growth of international research projects that are mainly based on making use of health-related data has increased the number of ethics reviews required. Unfortunately, this has caused problems with researchers, participants, and others, as the same ethics review process that applies to one research project at one location tends to also apply to research projects that are taking place in multiple countries. Because an ethics committee is often limited to a single hospital, university, clinic, or local geographic area, international research projects have to face multiple duplicative ethics reviews. As a result, these reviews are repeated many times over. This can delay research and use up financial resources that should instead be put towards science and medicine. These replicated reviews have not been shown to improve human subjects’ protections; they only cause problems for science and medical breakthroughs in advancing human health.

We believe that the ERE Policy will improve this current problematic environment by establishing an ethics review recognition framework, which we hope ultimately will create ‘recognition’ (in other words, acceptance) of ethics reviews from different ethics committees around the world, which will boost efficient and responsible data sharing.

BB: How can individuals or organizations implement this policy in their own data sharing activities?

ED:We would encourage individuals and organisations to speak with their relevant local regulatory bodies and ethics committees to encourage them to recognise and endorse this ERE Policy. Ultimately, the ERE Policy will only be successful if there is buy-in from all stakeholders across the world. Ethics committees and relevant regulatory bodies are important components in the data sharing ecosystem. Without their endorsement of this ERE Policy, global data sharing activities will be challenged (e.g. slowed down) by the ongoing problems with ethics reviews of international data-intensive research projects.

BB: Who will be using the ERE Policy and how would they benefit from it (ie., clinicians, data repositories,etc)?

ED:It is our hope and intention that the ERE Policy will be used by all stakeholders that match our GA4GH membership. This includes researchers and research institutions, research sponsors and funders, governments and regulatory bodies, research ethics committees, and research participants. All would benefit from this ERE Policy, since it seeks to set an effective baseline of the ethics review process for international research involving genomic and health-related data. Establishing a baseline should build trust in the ethics review process followed in another country and encourage recognition from other ethics committees and regulators of the ethics decision made by the ethics committee from this other country.

Also, we hope that this Policy will be useful to those who are responsible for drafting national, local, and institutional regulations and policies, as well as international national ethics committee accreditation systems, such that the possibility of ‘ethics review recognition’ (as we call it in the ERE Policy) can be enhanced.

BB: How does the new work meet a previously-unmet need for improved use and understanding of genomics for health?

ED:Since the first GA4GH plenary meeting was held at the Wellcome Trust in March 2014, members have expressed concern regarding ethics review processes for international research projects driven by sharing of genomic and health-related data. Specifically, they were concerned that the current process of reviews by multiple committees were causing long delays to research, which harms patients and participants. The Regulatory and Ethics Working Group established the Ethics Review Equivalency Task Team at the first plenary meeting to address this concern. The ERE Policy can be seen as a key output from that Task Team’s efforts to reduce inefficiencies in the ethics review system and to accelerate the sharing of genomic and health-related data.

BB: Is there anything else you'd like the community to know about the new ERE Policy?

ED: The ERE Policy, once finalised, will be followed-up in 2017 with ‘practical guidance’ for GA4GH members that would help them get their research proposals through ethics committees. This guidance would be based on real case studies or experiences from GA4GH members. We are very excited about the benefits this may have for our members. Stay tuned for more information!